You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
As a result of lacking documentation, missing data, or noted discrepancies, research professionals may turn to the use of a memo or note to file (NTF) to record and explain issues throughout a clinical trial.
We’ve all heard and advocated that “if it wasn’t documented, it wasn’t done”, but is a note to file the best way to remedy absent or deficient documentation?
Topics: Monitoring
Remote monitoring has been encouraged since 2011, but due to COVID-19, we are seeing remote monitoring of clinical trials being utilized more frequently.
The technology to allow for remote monitoring visits has grown significantly in the past few years. These technologies can include electronic Trial Master Files (TMF), Institutional Review Board (IRB) portals, remote access to the electronic medical records (EMR), and even secure source document sharing systems.
With these technologies, monitors can gain access remotely to the same information they would be provided if they were on site. However, you might be wondering if remote monitoring has any disadvantages, particularly when it comes to FDA inspections.
Topics: Monitoring
In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?
Topics: Auditing, Monitoring